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頁籤選單縮合
題 名 | 市售Diclofenac Sodium軟膏、凝膠、栓劑之品質調查=An Investigation for the Quality of Diclofenac Sodium Ointment, Gel and Suppositories from Taiwan District |
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作 者 | 許淑纓; 楊明玉; 黃明權; 溫國慶; 廖俊亨; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷 期 | 20 2002.09[民91.09] |
頁 次 | 頁24-33 |
分類號 | 412.36 |
關鍵詞 | 軟膏; 乳膠; 凝膠; 栓劑; 鑑別; 含量測定; Diclofenac sodium; Ointment; Emulgel; Gel; Suppositories; Identification; Assay; |
語 文 | 中文(Chinese) |
中文摘要 | 為瞭解臺灣地區現階段市售Diclofenac Sodium 軟膏、凝膠、栓劑之品質狀況,經函請北、高兩市及各縣市衛生局,於民國九十年四月至六月間,赴轄區內醫院、藥局、藥廠及輸入代理商抽驗市售檢體共計34 件(包括國產28 件,輸入6 件,分屬18 家藥廠所製造),參照原開發廠及各製造廠所制定之檢驗規格作外觀、內容量(乳膠、凝膠)、平均重量、重量差異(栓劑)、鑑別及含量測定等重點項目之檢驗。結果除「外觀檢查」不合格者1 件外,其餘各項均合格,不合格率為2.94%。本調查係本局之比較檢檢,曾於九十一年二月十一日發布新聞在案。 |
英文摘要 | In order to assess the quality of diclofenac sodium ointment、mulgel、gel and suppositories,thirty-four samples of different brand and lot numbers were purchased throughout Taiwan area from April to June 2001. The appearance, mean weight, minimum fills, identification and assay of all samples were inspected and were determined by the method described in the USP 24 and/or from the manufacturer. The results showed that all of the samples met the requirements except one sample for its appearance. |
本系統中英文摘要資訊取自各篇刊載內容。